NCT03003416CompletedNot Applicable
Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 115
- Locations
- 25
- Primary Endpoint
- Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Study Overview
Brief Summary
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.
Exclusion Criteria
- •Patient not residing in metropolitan France.
Arms & Interventions
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
Intervention: dexamethasone intravitreal implant (Drug)
Outcomes
Primary Outcomes
Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Time Frame: Baseline to Month 24
Secondary Outcomes
- Number of Participants with Cataract Surgeries Related to Treatment or Injection(24 Months)
- Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment)(24 Months)
- Change from Baseline in BCVA(Baseline, Week 6, Months 6, 12, 18 and 24)
- Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)(Day 1)
- Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline(Baseline, Week 6, Month 6, 12, 18 and 24)
- Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)(Day 1)
- Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)(24 Months)
- Percentage of Participants with Serious Adverse Events(24 Months)
- Time to Achieve Maximum Gain in BCVA(24 Months)
- Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline(Baseline, Week 6, Month 6, 12, 18 and 24)
- Change from Baseline in Retinal Thickness(Baseline, Month 24)
- Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline(Baseline, Month 24)
- Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness(Month 24)
- Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®(Day 1)
- Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline(24 Months)
- Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery(24 Months)
- Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections(Day 1)
- Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure)(Day 1)
- Number of Participants with Incident Cataracts(24 Months)
- Percentage of Participants with Death(24 Months)
- Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity(24 Months)
Investigators
Study Sites (25)
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